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New Cures Bill to Reconsider Conflict-of-Interest Rules

Nov. 28 — The updated
21st Century Cures bill may revise some financial disclosure requirements designed to prevent federally funded
scientists from cozying up to drug and device companies.

The House is expected to vote Nov. 30 on a newly revised Cures bill, which lawmakers
released late Nov. 25 as an amendment to the tsunami bill (H.R. 34). If enacted, the
21st Century Cures bill would culminate a three-year effort led by House Energy and
Commerce Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) to spur new
medical treatments.

Industry groups and research advocates generally hailed the new bill as a life-saving
measure that would provide billions of dollars in new funding for medical research
and seeks to transform an enterprise in which developing a single drug costs more
than $1 billion, takes a decade to complete and the
vast majority of investigational products fail in clinical trials.

But Public Citizen maintains some of the provisions remain problematic, and Sen. Charles
Grassley
(R-Iowa) said he opposed some of efforts to pull back on reporting requirements of
the
Open Payments law he authored.

Changes in Pay-Fors

The new Cures bill maintains much of the same language from the
version the House passed in 2015 (H.R. 6), and the reintroduction largely centers around changes in how to pay for
the bill and how much funding to provide to the National Institutes of Health and
the Food and Drug Administration (
see related story
).

“The base Cures bill itself looks pretty tame and is pretty much the same,”
Bloomberg Intelligence senior health-care analyst Brian Rye told Bloomberg BNA Nov.
28. Rye noted one of the revised pay-fors is a win for the brand-name drug industry.
The 2015 version of the bill excludes authorized generics when calculating the average
price for Medicaid rebates.

“If you exclude the generic price from the average, that raises the rebates that pharma
has to pay to Medicaid,” Rye told Bloomberg BNA Nov. 28.

But the latest Cures legislation has dropped some measures—including one on privacy--and
added some human subject research measures that weren’t in the July 2015 version.

“It’s not just about the money, Yes we care deeply about the money and the money is
integral,” Ellen V. Sigal, founder of
Friends of Cancer Research, told Bloomberg BNA Nov. 28. “But there are mechanisms that go beyond the money that
will really make for much more robust scientific infrastructure that will be working
for patients and that’s what we care about.”

Conflict of Interest

Heather H. Pierce, senior director of science policy and regulatory counsel for scientific
affairs of the
Association of American Medical Colleges, said many of the new provisions fold in recommendations from a September 2015
National Academies report on how to improve the regulation of research in the U.S. or from the Senate companion
effort to Cures led by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.).

“Most everything in here we’ve seen somewhere,” Pierce told Bloomberg BNA Nov. 28,
including the new conflict-of-interest language that comes directly from the National
Academies report.

Part of a section on reducing administrative burden (Section 26), the conflict-of-interest
provisions would require the Department of Health and Human Services to lead a review
of financial conflicts of interest. Pierce said it’s an effort to reconcile various
government financial relationship reporting requirements, which currently vary among
the different funding agencies.

If enacted, the new conflict-of-interest measures would come about five years after
the NIH went through a major overhaul of its own financial reporting requirements—the
first such effort in 16 years. That
policy both cut the NIH’s reporting threshold in half and increased the reporting requirements
for scientists.

Another new provision in the new Cures bill, Section 4009, would exempt “certain transfers
of value from reporting requirements that health care providers have noted have a
chilling effect on their engagement in important continuing medical education activities.”
Grassley said he plans to oppose the bill once it comes to the Senate unless lawmakers
remove this provision because it would water down industry reporting requirements
in his Sunshine law.

“We shouldn’t create a loophole that would let drug and medical device companies
mask their payments to doctors under a payment category that’s too broad and could
gut the spirit and the letter of the Sunshine Act,” Grassley said in a Nov. 28 statement.

Drug Exclusivity Changes

The bill also makes changes to some of the drug exclusivity language. Michael Carome,
director of
Public Citizen’s Health Research Group, pointed to a separate exclusivity provision of the 2015
bill that would have extended exclusivity periods for a drug approved for a new indication
for a rare disease or condition (Section 2151 of H.R 6).

Carome told Bloomberg BNA he supported the deletion of this measure in the 2016 version
because that language “would have increased drug prices and costs to taxpayers by
as much as $12 billion over 10 years by extending monopoly protections for brand-name
blockbuster drugs that receive additional approval to treat an orphan diseases.”

Potentially Harmful Provisions

While Carome acknowledged the bill has some improvements, Public Citizen continues
to oppose it. The group called on Congress not to rush the bill through, issuing a
statement of potentially harmful provisions.

One of those provisions, Section 3022, is the move to incorporate real-world evidence--data
gathered from clinical settings instead of a randomized, controlled trial--into the
FDA’s regulatory decisions. “This will weaken the standards for FDA review and approval
of supplemental new drug applications (sNDAs) and lower the bar for the type of evidence
needed to meet post-approval requirements,” the Public Citizen statement said.

But Sigal of Friends said the use of real-world evidence is incredibly important,
particularly to advance treatments on rare diseases.

“It doesn’t mandate that FDA use it,” she said about the Cures language on real-world
evidence. “It just gives them the ability to make the scientific decisions based on
the strength of the evidence.”

Evaluating how well a new drug works along with its risks and benefits remains the
gold standard for determining whether to approve it, she said. “We’re not supporting
anything that doesn’t have rigorous scientific data and doesn’t have efficacy,” she
said.

Privacy Protections

Kirk J. Nahra, a health privacy lawyer with
Wiley Rein LLP,
tweeted Nov. 28, “The worst
#HIPAA language from the House version of 21st Century Cures is gone--at least for now.”
He was referring to a provision in the 2015 bill that he said would have allowed FDA-regulated
companies to buy protected health information, which currently isn’t allowed under
the Health Insurance Portability and Accountability Act.

“When you’re writing the HIPAA rules, one of the things they’re worried about is drug
companies getting data to use for marketing purposes. And drug companies aren’t covered
by the HIPAA rules because they’re not covered entities. And this provision would
have let them buy PHI from anybody,” Nahra told Bloomberg BNA. “it would have basically
been a loophole removing all of the HIPAA protections for PHI.”

Other new provisions would:

establish a research policy board, an ongoing, White House-level body that would
evaluate U.S. research regulations;

support the Precision Medicine Initiative;

allow the secretary of HHS to exempt individual biomedical research data from being
disclosed if the data are identifiable, or could be used to identify a research subject;
and

broaden an existing
Certificates Confidentiality program that protects researchers from being compelled to disclose their research
data if subpoenaed.

To contact the reporter on this story: Jeannie Baumann in Washington at
jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at
RKubetin@bna.com

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